Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

NCT04885946 | Unknown DMC

• 1 other identifier: 1-10-72-254-20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined. In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.

Conditions

Clostridium Difficile Infection; Clostridioides Difficile Infection

Keywords

Fecal microbiota tranplantation, FMT, CDI

Outcome Measures

Primary Outcomes (2)

• Resolution of CD-associated diarrhea (CDAD) week 8

  Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.

  8 weeks following treatment

• Mortality week 8

  In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.

  8 weeks following treatment

Secondary Outcomes (6)

• Resolution of CD-associated diarrhea (CDAD) week 1

  1 week following treatment

• Negative CD toxin-test week 1

  1 week following treatment

• Negative CD toxin-test week 8

  8 weeks following treatment

• Mortality week 8

  8 weeks

• Colectomy rate week 8

  8 weeks

Study Arms (3)

Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation

EXPERIMENTAL

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.

Other: Fecal microbiota transplantion (FMT)

Vancomycin 125 x 4 for 10 days + 2 Placebo

PLACEBO COMPARATOR

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.

Other: Placebo

Open-label for screened, but not randomized patients with fulminant CDI

OTHER

This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.

Other: Fecal microbiota transplantion (FMT)

Interventions

Fecal microbiota transplantion (FMT) OTHER

Single donor, fecal microbiota transplantion (FMT) from healthy human donors.

Open-label for screened, but not randomized patients with fulminant CDI; Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation

Placebo OTHER

Food coloring, water, glycerol

Vancomycin 125 x 4 for 10 days + 2 Placebo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. or 2. CDI (within a year) defined as: \> 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
• Age 18 years or higher.

You may not qualify if:

• Pregnancy
• Does not speak or understand the Danish language
• Current antibiotic treatment other than vancomycin
• Current treatment with potential interations with vancomycin
• Allergy to vancomycin
• Previous anaphylactic reactions due to food allergies
• Continuous need for proton pump inhibitor
• Documented gastroparesis
• Fulminant CDI

Sponsors & Collaborators

• Christian Hvas: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1083-1091. doi: 10.1016/S2468-1253(22)00276-X. Epub 2022 Sep 22.

  PMID: 36152636 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Diabetes Insipidus, Neurogenic

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Christian L Hvas, PhD

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD Consultant

Model Details: Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: June 2, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)